November 7, 2025 - Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), announced that the first patient has been dosed in a Phase I clinical study for anti-tumor new drug candidate SIM0609 at Peking University Cancer Hospital.
This international, multicenter, open-label Phase I study is led by Professor Lin Shen of Peking University Cancer Hospital. It aims to evaluate the safety, pharmacokinetics, and anti-tumor activity of SIM0609 in subjects with advanced solid tumors. The study has been approved to be conducted in both China and the United States.
SIM0609 is a CDH17-targeting antibody-drug conjugate (ADC) developed independently by Simcere Zaiming. This molecule is composed of a humanized monoclonal antibody conjugated with Simcere Zaiming’s proprietary novel topoisomerase I (TOPO-I) inhibitor through the company’s proprietary water-soluble cleavable linker. CDH17 is highly expressed in various cancers, including gastric, colorectal, and pancreatic cancers, demonstrating potential as a therapeutic target for advanced solid tumors, particularly gastrointestinal malignancies.